Ischemic StrokePhase 1NCT00265408
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection
A Phase 1 study testing aspirin and warfarin in people with Ischemic Stroke, run by University of California, San Diego at 1 site in United States.
Trial summary
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- aspirin and warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and imaging diagnosis of cervicocephalic arterial dissection within 3 months.
Who cannot join
- Any contraindication to aspirin or warfarin.
Trial locations and contacts
1 site in 1 country.
About this study
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.
Read the detailed description
20 patients with cervicocephalic arterial dissection will be randomized to open-label aspirin or warfarin, rate of stroke and adverse events will be endpoints.
- Conditions
- Ischemic Stroke
- Keywords
- Cervicocephalic Arterial Dissection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aspirin | Experimental | Not described Receives: Drug: aspirin |
| warfarin | Experimental | Not described Receives: Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke by one year.
Measured: 1 year
Secondary outcomes (3)
Recurrent dissection by one year.
Measured: 1 year
Incidence of TIA by one year.
Measured: 1 year
Incidence of major and minor bleeding episodes by one year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startDec 2005
- Study completionMar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Matt B Jensen, MD, Principal investigator, UCSD Stroke Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265408
- Sponsor's protocol ID
- UCSD IRB #051253
- Status last verified
- Mar 2007
- First submitted
- 12 Dec 2005
- Last updated
- 8 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection
- ClinicalTrials.gov ID
- NCT00265408
- Acronym / sponsor ID
- UCSD IRB #051253
- Conditions
- Ischemic Stroke
- Keywords
- Cervicocephalic Arterial Dissection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Mar 2007 (estimated)
- First posted
- 14 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot Study of Aspirin Versus Warfarin for Cervicocephalic Arterial Dissection.
Detailed description
20 patients with cervicocephalic arterial dissection will be randomized to open-label aspirin or warfarin, rate of stroke and adverse events will be endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aspirin | Experimental | Drug: aspirin |
| warfarin | Experimental | Drug: warfarin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical and imaging diagnosis of cervicocephalic arterial dissection within 3 months.
Key exclusion criteria (1 listed)
- Any contraindication to aspirin or warfarin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin | Drug | aspirin |
| warfarin | Drug | warfarin |
Primary outcome
Incidence of stroke by one year.
Time frame: 1 year
3 secondary outcomes
Recurrent dissection by one year.
Time frame: 1 year
Incidence of TIA by one year.
Time frame: 1 year
Incidence of major and minor bleeding episodes by one year.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt B Jensen, MD principal investigator
UCSD Stroke Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aspirin and warfarin in people with Ischemic Stroke, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stroke by one year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.